NCT05360212

Anatomy-based Fitting in Cochear Implant Users

Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.

Detailed description

In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9. The performance with anatomy-based fitting is assessed by comparing performance with the CI in these two groups over time. The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.

Conditions

• Cochlear Implant
• Outcomes
• Quality of Life

Interventions

Type	Name	Description
PROCEDURE	Anatomy-based fitting (ABF)	MAESTRO 9 can display the tonotopic frequency of each individual electrode channel imported from OTOPLAN to further support fitting based on these measures. The audiologist can set a frequency-band distribution that is more closely aligned to the tonotopic frequency distribution as imported from OTOPLAN.
PROCEDURE	Standard Fitting	These group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9.
PROCEDURE	Standard fitting+ ABF	Patients of this group are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.

Timeline

• Start date: 2022-03-11
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2022-05-04
• Last updated: 2025-08-12

Locations

1 site across 1 country: Spain